Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Difference in coronary 68Ga-Dotatate uptake after treatment.
研究概览
简要总结
To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.
详细描述
We will use 68Ga-Dotatate PET/CT scans, bone marrow aspirations and peripheral blood analyses to determine the effect of type 2 diabetes on vascular wall inflammation, and hematopoietic stem cell composition, and whether these changes can be reversed using high dose semaglutide treatment, up to 2.0mg subcutaneously per week, for a period of six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >50 years old
- •Diagnosed with type 2 diabetes
- •HbA1c >64mmol/mol
排除标准
- •(History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- •Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml
- •Auto-immune diseases (including type 1 diabetes)
- •Recent or chronic immunosuppressant or antibiotic usage
- •Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.
- •Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- •Uncontrolled hypertension (systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg)
- •Uncontrolled chronic inflammatory conditions, including gout.
- •Women of childbearing age who are not using effective contraceptives.
- •Heart failure New York Heart Association (NYHA) class IV at screening visit.
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.
- •Pancreatitis in medical history.
研究组 & 干预措施
Treatment arm
Will receive semaglutide treatment for 6 months, at the highest tolerable dose, up to a maximum of 2.0mg weekly.
干预措施: Semaglutide, 2.0 mg/mL (Drug)
结局指标
主要结局
Difference in coronary 68Ga-Dotatate uptake after treatment.
时间窗: 6 months
The within subject comparison of 68Ga-Dotatate uptake in the coronary arteries before and after semaglutide treatment, expressed as a difference in TBRmax.
次要结局
- Difference in bone marrow aspirates after treatment.(6 months)
研究者
Nordin Hanssen
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)